Objective 1: Compare the ability to sucessfully insert IUDs without the use of adjunctive methods (use of ultrasound guidance, cervical dilation, or halting the procedure to administer anesthesia or analgesia) in nulliparous women who were randomly assigned to misoprostol 400 mcg or placebo.
Objective 2: Compare pain noted by nulliparous women undergoing IUD insertion who were randomly assigned to misoprostol 400 mcg or placebo measured by a uniform 100-mm validated visual analogue scale.
Table 1: Collaborative Group
Emory University School of Medicine
Oregon Health & Science University
University of Arizona
University of Colorado
University of New Mexico
University of Utah
The Collaborative Group for this PMA consist of six sites. These sites were selected because of their interest in IUD research and the specific subject matter. Sites were recruited from the membership of the Association of Reproductive Health Professionals, where the project was presented at an annual meeting (Minneapolis, Minnesota 2008). All sites have agreed to contribute their de-identified individual patient data (IPD) for the PMA. The Steering Committee for the Collaborative Group will consist of a representative from each site. The project is coordinated by David Turok at the University of Utah. The lead statistician for the PMA is Sara Simonsen. Kenneth Schulz is an additional member of the steering group who will contribute expertise in the fields of meta-analysis and trial design. The sites, their representative to the steering committee of the collaborative group, and target recruitment are described in Table 1.
Several things distinguish this PMA collaboration from a multi-center RCT. First, each site is free to create a unique protocol. Results from a site can be included in the PMA as long as they are properly randomized, examine the same intervention, and include outcome data on the primary and secondary endpoints of interest. Secondly, individual sites are free to publish their results independently. Finally, should other sites meet the above criteria they will be invited to join the Collaborative Group.
Because this is a PMA, only trials that have not yet published results prior to the initial posting of this protocol on the Cochrane website will be included. All included trials are or will be registered with a clinical trials registry. The members of the Steering Committee have agreed to register their individual trials with the National Institutes of Health Clinical Trials Registry (http://clinicaltrials.gov/). Three sites (Oregon Health and Science University, the University of Utah, and the University of Arizona) have obtained IRB approval for their studies. The remaining three sites are in the process of IRB approval. Future randomized trials of misoprostol vs. placebo prior to IUD insertion in nulliparous women that include the stated entry criteria as well as the primary and secondary outcomes listed above will be eligible for inclusion in this PMA as long as the results of any of the included studies are not known to anyone outside the Collaborative Group. This group will meet at least annually to discuss the project and have communication as needed to address issues of the PMA as they arise.
This is a protocol.